Why 89bio Shares Are Trading Higher Today

89bio ETNB shares are trading higher on Wednesday after the company's Phase 2b ENLIVEN trial of pegozafermin in NASH achieved statistical significance on both primary histology endpoints.

ENLIVEN is a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial designed to evaluate the safety and efficacy of weekly or every-two-week dosing of pegozafermin for the treatment of patients with fibrosis stage F2 - F3 NASH and NAS ≥ 4 for 48 weeks.

Pegozafermin continued to demonstrate a favorable safety and tolerability profile consistent with prior studies. Across dose groups, the most frequently reported treatment-related adverse events (AEs) were Grade 1 or 2 gastrointestinal events (diarrhea, nausea and increased appetite) most of which were mild to moderate in nature. Rates of treatment-related AEs observed were less frequent with the Q2W dosing regimen.

"These data are all the more significant given the rigor of the study methodology, including how the biopsies were read to reduce the impact of reader bias and variability. The ENLIVEN study followed a stringent analytical plan consistent with FDA guidance, and the low placebo response rate provides high confidence that this trial showed the true potential treatment effect of pegozafermin," said Arun J. Sanyal, MBBS, M.D., Professor, Departments of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University.

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases

Price Action: 89bio has a 52-week high of $15.5 and a 52-week low of $2.03.

89bio shares are up 28.3% at $14.03 at the time of writing, according to Benzinga Pro.